Simpex Medical Inc
FDA inspection history in Fort Mill, South Carolina, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Fort Mill, South Carolina.
Cited most
Across all Simpex Medical observations on file
- 21 CFR 820.120(b)Device labeling1
- 21 CFR 820.250(b)Statistical techniques1
- 21 CFR 820.30(b)Design controls1
- 21 CFR 820.72(a)Inspection, measuring, and test equipment1
- 21 CFR 820.75(a)Process validation1
The complete Simpex Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Fort Mill, South Carolina
One Form 483 · 2024 · 5 observations
Latest: Form 483, Jun 28, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-28 | 483 Form 483 | Fort Mill, South Carolina | 5 | $99 |
Investigators on these documents
FEI number 1000126034 · most recent document Jun 28, 2024
About Simpex Medical Inc
How many FDA Form 483s has Simpex Medical Inc received?
FDA Intel has 1 Form 483 on file for Simpex Medical Inc; the most recent is dated Jun 28, 2024.
When was Simpex Medical Inc last inspected by FDA?
The most recent FDA inspection document on file for Simpex Medical Inc is a Form 483 dated Jun 28, 2024, for the site in Fort Mill, South Carolina.
What did FDA cite at Simpex Medical Inc?
The regulations cited most in the observations on file for Simpex Medical Inc are 21 CFR 820.120(b) (Device labeling), 1 time; 21 CFR 820.250(b) (Statistical techniques), 1 time; 21 CFR 820.30(b) (Design controls), 1 time.